HBV-DNA载量水平与血清学标志物分组模式及前S1抗原的关系
| 作者: |
1沙启明
1 六安市中医院检验科，安徽 六安 237000 |
| 通讯: |
沙启明
Email: 523574137@qq.com |
| DOI: | 10.3978/j.issn.2095-6959.2022.01.005 |
摘要
目的：探讨乙型肝炎病毒DNA(hepatitis B virus DNA，HBV-DNA)载量水平与血清学标志物(hepatitis B virus markers，HBVM)分组模式以及前S1抗原(Pre-S1 antigen，Pre-S1Ag)的关系。方法：收集2018年6月至2020年7月来院就诊的180例慢性乙肝患者的血清样本，采用实时荧光定量聚合酶链反应(qRT-PCR)技术检测血清HBV-DNA载量水平；采用化学发光免疫分析法(CLIA)检测乙肝表面抗原(HBsAg)、e抗原(HBeAg)、表面抗体(抗HBs)、e抗体(抗HBe)、核心抗体(抗HBc)，并归纳受检样本的HBVM分组模式；采用ELISA法检测血清Pre-S1Ag。分析HBV-DNA载量水平、HBVM分组模式和Pre-S1Ag水平的关系。结果：180例血清样本，HBsAg+/抗HBe+/抗HBc+模式85例(47.22%)，HBsAg+/HBeAg+/抗HBc+模式70例(38.89%)，其他模式25例(13.89%)。HBsAg+/HBeAg+/抗HBc+模式组HBV-DNA、Pre-S1Ag阳性率均明显高于HBsAg+/抗HBe+/抗HBc+模式组及其他模式组，差异有统计学意义(χ2=56.955、46.809，P<0.05)。将HBV-DNA阳性作为判断HBV复制的金标准，HBeAg的灵敏度为87.23%，特异度为65.12%，阳性预测值为73.21%，阴性预测值为82.35%；Pre-S1Ag的灵敏度为90.35%，特异度为86.36%，阳性预测值为91.96%，阴性预测值为83.82%。依据HBV-DNA载量检测水平，分成<103 copies/mL、103~105 copies/mL、105~107 copies/mL、>107 copies/mL的4个亚组。随着HBV-DNA载量水平升高，Pre-S1Ag阳性率逐渐升高，分别为41.18%、64.00%、77.78%、94.29%，差异具有统计学意义(χ2=31.250，P<0.05)。结论：HBV血清学标志物和Pre-S1Ag均可用于辅助诊断是否感染HBV以及HBV复制水平，但尚不可取代HBV-DNA定量检测，三者联合检测能为临床诊断、病毒复制提供更全面的依据。
关键词：
乙型肝炎病毒载量；荧光定量聚合酶链反应技术；血清学标志物模式；化学发光免疫分析法；前S1抗原；ELISA法
Relationship between HBV-DNA load levels and grouping mode of serological markers and Pre-S1 antigen
CorrespondingAuthor: SHA Qiming Email: 523574137@qq.com
DOI: 10.3978/j.issn.2095-6959.2022.01.005
Abstract
Objective: To explore the relationship between hepatitis B virus (HBV) DNA (HBV-DNA) load levels and grouping mode of serological markers of hepatitis B (HBVM) and Pre-S1 antigen (Pre-S1Ag). Methods: Serum samples were collected from 180 patients with chronic hepatitis B who came to the hospital for treatment between June 2018 and July 2020. Serum HBV-DNA load levels were detected by quantitative real-time polymerase chain reaction (qRT-PCR). Hepatitis B surface antigen (HBsAg), hepatitis e antigen (HBeAg), surface antibody (anti-HBs), e antibody (anti-HBe) and core antibody (anti-HBc) were detected by chemiluminescence immunoassay (CLIA), and the HBVM grouping mode of the samples was summarized. Serum Pre-S1Ag was detected by enzyme linked immunosorbent assay (ELISA). The relationship between HBV-DNA load levels, HBVM grouping mode and Pre-S1Ag level was analyzed. Results: Among the 180 serum samples, there were 85 cases (47.22%) of HBsAg+/anti-HBe+/anti-HBc+ mode, 70 cases (38.89%) of HBsAg+/HBeAg+/anti-HBc+ mode and 25 cases (13.89%) of other modes. The positive rates of HBV-DNA and Pre-S1Ag in HBsAg+/HBeAg+/anti-HBc+ mode group were significantly higher than those in HBsAg+/anti-HBe+/anti-HBc+ mode group and other mode group (χ2=56.955, 46.809, P<0.05). The sensitivity, specificity, positive predictive value and negative predictive value of HBeAg were 87.23%, 65.12%, 73.21% and 82.35% respectively when positive HBV-DNA was used as the gold standard for judging HBV replication. The sensitivity, specificity, positive predictive value and negative predictive value of Pre-S1Ag were 90.35%, 86.36%, 91.96% and 83.82% respectively. According to the HBV-DNA load detection levels, the patients were divided into four subgroups, including <103 copies/mL, 103–105 copies/mL, 105–107 copies/mL and >107 copies/mL subgroups. With the increase of HBV-DNA load levels, the positive rate of Pre-S1Ag was gradually increased, which were 41.18%, 64.00%, 77.78% and 94.29% respectively, with a statistically significant difference (χ2=31.250, P<0.05). Conclusion: Both serological markers of HBV and Pre-S1Ag can be used to assist in the diagnosis of HBV infection and HBV replication levels, but they cannot replace HBV-DNA quantitative detection, and the combined detection of the three indicators can provide a more comprehensive basis for clinical diagnosis and viral replication.
Keywords：
hepatitis B virus load; quantitative real-time polymerase chain reaction; serological marker mode; chemiluminescence immunoassay; Pre-S1 antigen; enzyme linked immunosorbent assay